Deep-sea Fish Oil for Prevention of Acute Radiation-induced Esophagitis (NCT06392971) | Clinical Trial Compass
UnknownPhase 2
Deep-sea Fish Oil for Prevention of Acute Radiation-induced Esophagitis
China120 participantsStarted 2023-01-15
Plain-language summary
Purpose：To observe and evaluate the clinical efficacy and safety of deep-sea fish oil in preventing acute radiation-induced esophagitis (ARIE).
Methods and Materials：A total of 120 patients with esophageal cancer treated with radiotherapy were randomly assigned (1:1) to treatment or control group. In the treatment group, 1g deep-sea fish oil was oral administrated prophylactically twice a day，the control group was blank control. The clinical efficacy of deep-sea fish oil on prevention of ARIE was evaluated by comparing the differences in the occurrence time, the grade and incidence of ARIE. Additionally, the change in nutritional status was also investigated. Hemanalysis, liver function, kidney function changes， and adverse reactions were compared before and after treatment to evaluate the safety of deep-sea fish oil.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18 years old, ≤70 years old, gender is not limited;
. Histological or cytological evidence of esophageal, lung, or breast cancer;
. ECOG score of 0-2, no swallowing pain or severe dysphagia before radiotherapy;
. Liver and kidney function, bone marrow function and cardiopulmonary function are not contraindicated by radiotherapy and chemotherapy;
. PG-SGA score \<9;
. Not pregnant or breastfeeding;
. The subject must understand and sign the informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The duration from initiation of radiotherapy to the onset of acute radiation esophagitis
Timeframe: Approximately 2 months
2
Severity of acute radiation esophagitis
Timeframe: Approximately 2 months
3
Incidence of severe acute radiation esophagitis
Timeframe: Approximately 2 months
Trial details
NCT IDNCT06392971
SponsorFirst Affiliated Hospital of Chengdu Medical College
. Have reading comprehension ability and can complete the questionnaire with medical assistance;
Exclusion criteria
. Prior radiation therapy;
. Patients with severe underlying diseases, who cannot tolerate radiotherapy and chemotherapy due to severe liver and kidney insufficiency and poor cardiopulmonary function;
. Pregnant or lactating female patients;
. Suffering from severe mental illness and poor compliance;
. Other cases deemed unsuitable for inclusion by the researchers.